Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000868583
Ethics application status
Approved
Date submitted
22/07/2015
Date registered
21/08/2015
Date last updated
21/08/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of a group-based low-intensity Cognitive Behavioural Therapy (CBT) self-help programme for older adults experiencing low mood.
Scientific title
Group-based CBT Self-help: Investigating the Usefulness of ‘Living Life to the Full’ classes in Improving Low Mood, Anxiety, and Quality of Life Amongst Community-Dwelling Older Adults.
Secondary ID [1] 287134 0
Nill
Universal Trial Number (UTN)
U1111-1169-9379
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Symptoms of depression (i.e., low mood) 295680 0
Symptoms of Anxiety (e.g., stress and worry) 295681 0
Condition category
Condition code
Mental Health 295954 295954 0 0
Depression
Mental Health 295955 295955 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The LLTTF programme is life skills educational course based on CBT principles. The programme will be facilitated by the Lead researcher Doctorate of Clinical Psychology Candidate James Martyn. The facilitator will undergo weekly supervision regarding the classes with a registered clinical psychologist who specialises in older adult health (Associate Professor Paul Merrick). Classes will run once a week, for eight weeks, with classes taking approximately 1.5 hours. Measures will be taken each week, which will also act as an indication of attendance.

The programme is designed to guide individuals to construct a self-assessment of their current experiences in a supportive group environment, while also enabling members to develop the life skills necessary to deal with challenges common to symptoms of depression and anxiety, both in and out of class. As such, the programme is a group-guided self-help course, not a therapy group. The programme utilises PowerPoint slides, lecture notes/scripts, worksheets, and self-help workbooks specific to each class topic. The self-help workbooks are also designed to facilitate the practice of CBT skills predominantly out of the class context throughout the following week. Each class contains a mixture of didactic teaching, question and answers, as well as group- and pair-based activities. Weekly class topics are titled: 1) Why do I feel so bad?; 2) I can’t be bothered doing anything; 3) Why does everything always go wrong?; 4) I’m not good enough (low confidence); 5) How to fix almost everything; 6) The things you do that mess you up; 7) Are you strong enough to keep your temper?; 8) Ten things you can do to help you feel happier straight away. Both the class content and the materials provided use everyday language and avoid professional terminology so as to make the CBT information easily understandable and applicable. Each class involves 10-15 minuet tea and coffee time, 15 minutes for session psychometric measures, and 70 minutes of class activity time. The total time will be no longer than 105 minutes.
Intervention code [1] 292393 0
Treatment: Other
Intervention code [2] 292442 0
Behaviour
Comparator / control treatment
I will be running only one group with no wait-list or controls. The statistical analysis I will be using is called Multi-Level Hierarchical Modeling. This allows the investigation of both within & between-subject variables.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295638 0
Depression will be measured using a Patient Health Questionnaire-9 (PHQ-9) with scores greater than 4 and less than 20 included in the study, as well as a Visual Analogue Scale.
Timepoint [1] 295638 0
Analysis will be measuring trajectories of change at ten time-points. One measure will be taken during screening. Eight measures will be taken weekly at the start of the eight classes. Finally, one measure will be taken at an eight-week follow-up.
Secondary outcome [1] 316055 0
Anxiety will be measured using a Geriatric Anxiety Scale (GAI) as well as a Visual Analogue Scale.
Timepoint [1] 316055 0
Analysis will be measuring trajectories of change at ten time-points. One measure will be taken during screening. Eight measures will be taken weekly at the start of the eight classes. Finally, one measure will be taken at an eight-week follow-up.
Secondary outcome [2] 316056 0
Quality of life will be measured using a Quality of Life and Enjoyment Questionnaire-Short Form (Q-LES-Q-SF) as well as a Visual Analogue Scale.
Timepoint [2] 316056 0
Analysis will be measuring trajectories of change at ten time-points. One measure will be taken during screening. Eight measures will be taken weekly at the start of the eight classes. Finally, one measure will be taken at an eight-week follow-up.
Secondary outcome [3] 316057 0
Engagement will be measured using a purpose-designed Participant Engagement Questionnaire that has three visual analogue scales asking participants their satisfaction with their reading, thinking, and application of skills out side of class.
Timepoint [3] 316057 0
Participants will be asked to complete the engagement questionnaire at eight time points. Time points will be weekly, from the second class and at the final two-month follow-up. The engagement measure will only be administered from the second class, as the measure asks about their engagement with class materials outside of the class over the previous week.

Eligibility
Key inclusion criteria
Participants will be required to be community dwelling (i.e., living independently without the current need for ongoing part-time or full-time assistance such as residential care) and be between 60 and 75 years of age. Additionally, participants must present with mild to moderately-severe symptoms of depression, with scores of between 5 (below 5 reflects minimal symptoms) and 19 (above 19 reflects severe symptoms) on the PHQ-9. Participants must be able to read, write, speak, and understand English, must be able travel to the classes, and not be currently receiving psychotherapy.
Minimum age
60 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals will not be asked to participate in the study if you fail to meet the inclusion criteria. Additionally, individuals will not be included if they state that their doctor or anyone else has expressed any serious concerns about your cognitive functioning. Finally, they will also not be able to attend if they are currently receiving psychotherapy or they have a current diagnosis (or serious concerns about) alcohol abuse, substance abuse, psychosis, bipolar disorder, or borderline personality disorder. Individuals who fail to meet the aforementioned criteria will be informed via letter that they did not meet criteria and will not be asked to continue in the study. However, unsuccessful applicants will be provided with information concerning where they can access alternative LLTTF content.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
As the classes are non-randomised, there is no allocation to treatment. All individuals who show interest in the study are sent an information pack with screening material. Material is returned in a pre-paid envelop to one of the study supervisors. The supervisor de-identifies the information and gives the questionnaires to the primary investigator to score. The Investigator scores the information, any information that is found to not meet criteria is discussed with the primary supervisor, and then the individual is told of this decision by mail. They are however provided with alternative ways of accessing the content on their own behalf.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary analysis will be performed using multi-level modelling (MLM; Singer & Willett, 2003). The use of MLM allows for time to be treated as a continuous variable, separate to that of other individual variables of interest. This enables different levels of longitudinal data to be simultaneously investigated. In contrast to examining group averages over time, MLM allows the development of individual growth models. In doing so, individual trajectories can be established, which enables the investigation of both within- and between-subject variables. That is, relationships can be derived from within an individual’s data over time (Level 1) and in the data between individuals (Level 2; Kwok et al., 2008). MLM is also advantageous in that its assumptions regarding a sample and its size are flexible enough to accommodate factors such as an unbalanced designs, attrition, and missing data. Therefore, given the benefits and flexibility provided by MLM, particularly with longitudinal data sets, there is good rationale for the use of MLM in the proposed study.

Upon investigating the best analysis for my proposed study, a known issue was that it would be very difficult to gain a sufficient sample size given a number of practical study limitations. With this in mind, the primary researcher choose the best analysis (with statistical consultation) that provides enough descriptive information (individual and group trajectories) that can be used alongside inferential analysis (creating hierarchical prediction models) with lower power. Rather than a pre-post design, this analysis provides much richer information, showing shapes and stages of change over time. These facts in addition to the amount of variables needed to calculate a power analysis for MLM, the small amount of research done with group low-intensity work to obtain data to estimate data for a power analysis, and the differing arguments in literature as per the minimum sample size in each level, thereby combined to make an official power or sample size analysis too difficult. With this in mind, we will be doing a retrospective power analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2015
Actual
13/07/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 7045 0
New Zealand
State/province [1] 7045 0
Auckland.

Funding & Sponsors
Funding source category [1] 291693 0
University
Name [1] 291693 0
Massey University
Country [1] 291693 0
New Zealand
Primary sponsor type
Individual
Name
Associate Professor Paul Merrick
Address
School of Psychology
Massey University
Private Bag 102904 N.S.MC.
Auckland, 0632.
Country
New Zealand
Secondary sponsor category [1] 290368 0
University
Name [1] 290368 0
Massey University (New Zealand)
Address [1] 290368 0
School of Psychology
Massey University
Private Bag 102904 N.S.MC.
Auckland, 0632.
Country [1] 290368 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293219 0
Health and Disability Northern B Ethics Committee
Ethics committee address [1] 293219 0
Health and Disability Ethics Committees
Ministry of Health
c/- MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO BOX 5013
Wellington
6011
Ethics committee country [1] 293219 0
New Zealand
Date submitted for ethics approval [1] 293219 0
11/02/2015
Approval date [1] 293219 0
20/05/2015
Ethics approval number [1] 293219 0
15/NTB/51

Summary
Brief summary
The proposed study has two aims. First, the study aims to investigate the effect of a group-based CBT self-help programme (LLTTF) on community dwelling older adults ratings of depression, anxiety, and quality of life. Second, the study aims to investigate whether there is a positive relationship between community dwelling older adults’ engagement with the LLTTF programme and improvements in their perceived ratings on primary outcome measures.
Trial website
http://wellbeing.massey.ac.nz
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58954 0
Mr James Martyn
Address 58954 0
Attention: James Martyn
Massey University
Centre of Psychology
Private Bag 102904 N.S.M.C
Auckland, 0632.
Country 58954 0
New Zealand
Phone 58954 0
+64 273744984
Fax 58954 0
Email 58954 0
[email protected]
Contact person for public queries
Name 58955 0
Mr James Martyn
Address 58955 0
Attention: James Martyn
Massey University
Centre of Psychology
Private Bag 102904 N.S.M.C
Auckland, 0632.
Country 58955 0
New Zealand
Phone 58955 0
+64 273744984
Fax 58955 0
Email 58955 0
[email protected]
Contact person for scientific queries
Name 58956 0
Mr James Martyn
Address 58956 0
Attention: James Martyn
Massey University
Centre of Psychology
Private Bag 102904 N.S.M.C
Auckland, 0632.
Country 58956 0
New Zealand
Phone 58956 0
+64 273744984
Fax 58956 0
Email 58956 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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